Nadofaragene firadenovec-vncg (Urinary bladder)

Nadofaragene Firadenovec-vncg is used to treat patients who have high-risk Bacillus Calmette-Guerin (BCG)-unresponsive, non-muscle invasive bladder cancer (NMIBC) with a tumor type known as carcinoma in situ (CIS), with or without papillary tumors.

This medicine should only be used by or under the direct supervision of a doctor.

It is very important for your doctor to monitor your progress during regular visits to ensure that this medicine is working properly. Blood and urine tests will be needed to check for any unwanted effects.

If you are a woman who can become pregnant, your doctor may perform tests to confirm that you are not pregnant before starting this medicine. Using this medicine while pregnant can harm your unborn baby. Female patients should use an effective form of birth control during treatment and for at least 6 months after the last dose. Male patients with female partners should use an effective form of birth control during treatment and for at least 3 months after the last dose. If you think you might be pregnant while using this medicine, inform your doctor immediately.

In deciding to use a medicine, you and your doctor need to consider the risks of taking the medicine against the benefits it will provide. For this medicine, keep the following in mind:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know if you have any other types of allergies, like to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

Studies have not been done to determine how age affects the effects of Adstiladrin® in children. Safety and effectiveness have not been established for this group.

Geriatric

Studies conducted so far have not shown any age-related issues that would limit the usefulness of Adstiladrin® in older adults.

Breast Feeding

There are no sufficient studies in women to determine the risk to infants when using this medicine during breastfeeding. Weigh the potential benefits against the possible risks before taking this medicine while breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while others may be used together even if there could be an interaction. In these cases, your doctor may adjust the dose or take other precautions. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around mealtime or with certain types of food due to possible interactions. Using alcohol or tobacco with some medicines may also lead to interactions. Discuss with your healthcare professional how to use your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect the use of this medicine. Make sure to tell your doctor if you have any other medical conditions, especially:

• Immune system problems—Use with caution. May increase the risk for infection.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor or nurse immediately if any of the following side effects occur:

More common

• Blood in the urine
• burning while urinating
• chills
• difficult or painful urination
• fever
• trouble in holding or releasing urine
• unusual tiredness or weakness

Less common

• Anxiety
• arm, back, or jaw pain
• blurred vision
• chest pain, discomfort, heaviness, or tightness
• cold sweats
• coma
• confusion
• cool, pale skin
• decreased urination
• depression
• dizziness
• dry mouth
• fainting
• fast or irregular heartbeat
• headache
• lightheadedness
• nausea
• nervousness
• nightmares
• rapid breathing
• seizures
• shakiness
• slurred speech
• sunken eyes
• sweating
• thirst
• trouble breathing
• wrinkled skin

Rare

• Dilated neck veins
• blue or pale skin
• irregular breathing
• problems with movement, walking, or speech
• swelling of the face, fingers, feet, or lower legs
• vomiting
• weight gain

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

In the U.S.

• Adstiladrin

Available Dosage Forms:

• Suspension

Therapeutic Class: Antineoplastic Agent

A nurse or other trained health professional will give you this medicine in a hospital or clinic. This medicine is given through a tube (catheter) that is placed into your bladder once every 3 months.

This medicine comes with a patient information insert. Read and follow the instructions carefully. Ask your doctor if you have any questions.

Your doctor will give you other medicine (eg, an anticholinergic) before you receive this medicine.